COVID-19 Clinical Trial
— LOVITOfficial title:
Lessening Organ Dysfunction With VITamin C (LOVIT)
Verified date | March 2022 |
Source | Université de Sherbrooke |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
LOVIT is a multicentre concealed-allocation parallel-group blinded randomized controlled trial to ascertain the effect of high-dose intravenous vitamin C compared to placebo on mortality or persistent organ dysfunction at 28 days in septic intensive care unit patients. Patients with COVID-19 are considered eligible for this study.
Status | Completed |
Enrollment | 872 |
Est. completion date | January 24, 2022 |
Est. primary completion date | August 15, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Admitted to the intensive care unit with proven or suspected infection as the main diagnosis; 2. Currently treated with a continuous IV infusion of vasopressors (norepinephrine, epinephrine, vasopressin, dopamine, phenylephrine). Exclusion Criteria: 1. > 24 hours of intensive care unit admission; 2. Known Glucose-6-phosphate dehydrogenase (G6PD) deficiency; 3. Pregnancy; 4. Known allergy to vitamin C; 5. Known kidney stones within the past 1 year; 6. Received any intravenous vitamin C during this hospitalization unless incorporated in parenteral nutrition; 7. Expected death or withdrawal of life-sustaining treatments within 48 hours; 8. Previously enrolled in this study; 9. Previously enrolled in a trial with which co-enrolment is not allowed. The LOVIT trial has broad eligibility criteria and includes patients with a primary diagnosis of sepsis of any cause (including sepsis caused by viral pathogens as COVID-19). |
Country | Name | City | State |
---|---|---|---|
Canada | Research Center of the CHUS | Sherbrooke | Quebec |
Lead Sponsor | Collaborator |
---|---|
Université de Sherbrooke | Lotte & John Hecht Memorial Foundation |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of deceased participants or with persistent organ dysfunction | Defined as death or dependency on mechanical ventilation, renal replacement, or vasopressors | Both assessed at 28 days | |
Secondary | Number of participants with persistent organ dysfunction-free days in intensive care unit | Persistent organ dysfunction-free days in intensive care unit | Up to day 28 | |
Secondary | Number of participants deceased at 6 months | Mortality at 6 months | 6 months | |
Secondary | Score of health related quality of life in 6-month survivors | Assessed by the questionnaire EuroQol-5D (EQ-5D-5L). The EQ-5D-5L essentially consists of 2 pages: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS).
The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state. The EQ VAS records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'. |
6 months | |
Secondary | Global tissue dysoxia | Assessed by serum lactate concentration | Days 1, 3, 7 | |
Secondary | Organ function (including renal function) | Assessed by the Sequential Organ Failure Assessment (SOFA) score. Used to track a person's status during the stay in an intensive care unit to determine the extent of a person's organ function or rate of failure. The score is based on 6 different sub-scores, one each for the respiratory (PaO2/FiO2 mmHg), cardiovascular (mean arterial pressure OR administration of vasopressors required), hepatic (liver bilirubin (mg/dl) [µmol/L]), coagulation (platelets×103/µl), renal (kidneys creatinine (mg/dl) [µmol/L] (or urine output)) and neurological (Glasgow coma scale). The sub-score of each system ranges from 0 (best) to +4 (worst). | Days 1, 2, 3, 4, 7, 10, 14, 28 | |
Secondary | Rate of inflammation | Assessed by interleukin-1 beta (IL-1ß), tumor necrosis factor-alpha (TNF-a), C-reactive protein (CRP). | Days 1, 3, 7 | |
Secondary | Rate of infection | Assessed by procalcitonin (PCT) | Days 1, 3, 7 | |
Secondary | Rate of endothelial injury | Assessed by thrombomodulin (TM) and angiopoietin-2 (ANG-2) | Days 1, 3, 7 | |
Secondary | Occurrence of stage 3 acute kidney injury | Assessed by KDIGO (Kidney Disease: Improving Global Outcomes) criteria | Up to day 28 | |
Secondary | Acute hemolysis | clinician judgment of hemolysis, as recorded in the chart, OR
hemoglobin drop of at least 25 g/L within 24 hours of a dose of investigational product PLUS 2 of the following: reticulocyte count >2 times upper limit of normal at clinical site lab; haptoglobin < lower limit of normal at clinical site lab; indirect (unconjugated) bilirubin >2 times upper limit of normal at clinical site lab; Lactate dehydrogenase (LDH) >2 times upper limit of normal at clinical site lab. Severe hemolysis: - hemoglobin < 75 g/L AND at least 2 of the above criteria AND requires 2 units of packed red blood cells |
Up to day 28 | |
Secondary | Hypoglycemia | Core lab-validated glucose level of less than 3.8 mmol/L | During the time participants receive the 16 doses of the investigational product and the 7 days following the last dose | |
Secondary | Vitamin C volume of distribution | Assessed by chromatography-tandem mass spectrometry | 8th dose of vitamin C at time 0 (immediately prior to the dose) and then after administration at times 1 hour, 2 hours, 4 hours and 6 hours (Pharmacokynetic substudy) | |
Secondary | Vitamin C clearance | Assessed by chromatography-tandem mass spectrometry | 8th dose of vitamin C at time 0 (immediately prior to the dose) and then after administration at times 1 hour, 2 hours, 4 hours and 6 hours (Pharmacokynetic substudy) | |
Secondary | Vitamin C plasma concentration | Assessed by chromatography-tandem mass spectrometry | 8th dose of vitamin C at time 0 (immediately prior to the dose) and then after administration at times 1 hour, 2 hours, 4 hours and 6 hours (Pharmacokynetic substudy) |
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